The PREPAIRD Study: Personalized Surveillance for Early Detection of Pancreatic Cancer in High Risk Individuals (PREPAIRD)

February 13, 2023 updated by: Eli Marie Grindedal, Oslo University Hospital

The PREPAIRD Study: Personalized suRveillance for Early Detection and Prevention of Pancreatic cAncer in High Risk inDividuals

The objective of this national and multidisciplinary project is to establish and evaluate a personalized surveillance program (SP) for early diagnosis of pancreatic cancer (PC) and its precursors in individuals with a hereditary predisposition to the disease (High RIsk Individuals (HRI)). Patients who either carry a germline mutation in a PC susceptibility gene (CDKN2A, STK11, TP53, PRSS1), or have a strong family history of PC, will be enrolled through their genetics clinic at the university hospitals in Oslo, Bergen, Trondheim and Tromsø. Surveillance consists of annual MRI, assessment of blood glucose and lipid levels, new onset diabetes (NOD) and unintentional weight loss. Blood samples will be drawn for ctDNA-analysis (circulating tumor DNA) and the IMMrayTM PanCan-d test (a novel microarray-based diagnostic test for PC) at baseline and in those who develop lesions. The psychological burden and cost-benefit of the SP will be analyzed. The study addresses an unmet need for the care of HRI in Norway, and is expected to improve PC prognosis. It will be the first to provide evidence on the combined value of a panel of blood-borne biomarkers in surveillance, and provide morphological and molecular data on PC and (non)-neoplastic pancreatic changes in HRI.

Study Overview

Status

Enrolling by invitation

Conditions

Hereditary Pancreatic Cancer

Intervention / Treatment

Other: Annual surveillance

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway
    - Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men or women with a germline mutation in CDKN2A, TP53, PRSS1 or STK11
Men or women who are first degree relatives to a patient with pancreatic cancer (PC) in a family with Familial Pancreatic Cancer (FPC).

Exclusion Criteria: Patients undergoing active cancer treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Screening
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognosis of pancreatic cancer in patients diagnosed through the surveillance programme compared to prognosis in unscreened individuals as reported to the Cancer Registry of Norway. Time Frame: Up to 20 years	We will investigate whether 3 year, 5 year and long term survival in HRIs undergoing surveillance is improved compared to rates of survival of pancreatic cancer in the general unscreened population. Survival data for the general population will be collected from the Cancer Registry of Norway. Data on prognosis of pancreatic cancer in patients undergoing surveillance will be collected from electronic patient records, The Cancer Registry of Norway and the National Population Register.	Up to 20 years
Number of resectable cancers detected in patients diagnosed through the surveillance programme compared to the unscreened individuals as reported to the Cancer Registry of Norway. Time Frame: 20 years	We will investigate whether the number of surgically resectable cancers is higher in HRIs undergoing screening through the surveillance programme compared to pancreatic cancer diagnosed in the general population of Norway. Data on number of resectable cancers in the general Norwegian population will be collected from the Cancer Registry of Norway. Data on cancers diagnosed in the HRI will be collected from electronic patient records and The Cancer Registry of Norway.	20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization Time Frame: 20 years	Use of medication and specialist health care services. Data collected from administrative registries.	20 years
Quality of life of participants undergoing surveillance as assessed with the Hospital Anxiety and Depression Scale (HADS) Time Frame: 10 years	The quality of life of participants undergoing surveillance will be assessed with the Hospital Anxiety and Depression Scale (HADS) at baseline, after first, second and third MRI and then every three years.	10 years
Costs Time Frame: Up to 20 years	Health care utlization will be combined with Norwegian unit costs and summarized up to 20 years.	Up to 20 years
Cost-effectiveness analysis Time Frame: Up to 20 years	Differences in costs between study population and unscreened pancreatic cancer patients in the general population. Differences in survival in the PREPAIRD-study population and pancreatic cancer patients in the general population, identified from the Cancer Registry of Norway. The health outcome is identified in primary objective one. Based on difference in costs and life years, the incremental cost-effectiveness ratio will be estimated.	Up to 20 years
Quality of life of participants undergoing surveillance as assessed with the Impact of Event Scale (IES) Time Frame: 10 years	he quality of life of participants undergoing surveillance will be assessed with the Hospital Anxiety and Depression Scale (HADS) at baseline, after first, second and third MRI and then every three years.	10 years
The cancer worry of participants undergoing surveillance as assessed with the Cancer Worry Scale Time Frame: 10 years	The cancer worry of undergoing surveillance will be assessed with the Cancer Worry Scale at baseline, after first, second and third MRI and then every three years.	10 years
The general health of participants undergoing surveillance as assessed with the General Health Questionnaire Time Frame: 10 years	The cancer worry of undergoing surveillance will be assessed with the General Health Questionnaire at baseline, after first, second and third MRI and then every three years.	10 years
The psychological consequences of undergoing screening for pancreatic cancer as assessed by the Psychological Consequences of Screening questionnaire Time Frame: 10 years	The psychological consequences of undergoing screening for pancreatic cancer will be assessed with the Psychological Consequences of Screening questionnaire at baseline, after first, second and third MRI and then every three years.	10 years
The general health of participants undergoing surveillance as assessed by the Genereal Health questionnaire Time Frame: 10 years	The general health of individuals undergoing screening for pancreatic cancer will be assessed with the General Health Questionnaire at baseline, after first, second and third MRI and then every three years.	10 years
The psychological well-being of participants undergoing surveillance as assessed by the Psychological Well-being Questionnaire Time Frame: 10 years	The psychological well-being of individuals undergoing screening for pancreatic cancer will be assessed with the Psychological Well-being Questionnaire at baseline, after first, second and third MRI and then every three years.	10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

University Hospital of North Norway

University of Bergen

Helse Stavanger HF

Haukeland University Hospital

St. Olavs Hospital

Helse Sor-Ost

Immunovia, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

December 31, 2042

Study Completion (Anticipated)

December 31, 2042

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Estimate)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)